Plain English Summary

Trial website

Contact information

Type

Primary contact

ORCID ID

Contact details

Department of Social Medicine University of Bristol Canynge Hall Whiteladies Road Bristol BS8 2PR United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9711788

Study information

Scientific title

Acronym

Study hypothesis

The trial aims to identify the effectiveness of low cost self-help health education materials implemented within routine UK antenatal care in helping pregnant women quit smoking, using validated smoking status at the end of the second trimester of pregnancy (27 weeks) as the primary outcome measure. Secondary aims of the research will be (i) to collect data on birth weight, gestation at delivery and stillbirth and neonatal/infant mortality to contribute to the cumulative meta-analysis of the impact of smoking cessation on these outcomes; (ii) to assess the acceptability of the booklets to the women and (iii) to assess the feasibility and cost of incorporating self-help manuals dispatched by post into routine antenatal care

Ethics approval

Three NHS trusts agreed to participate in the study, and approval from relevant local research ethics committees were obtained

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Public health, social medicine

Intervention

Low cost self-help health education materials/control.

There will be two experimental groups: (i) participants receiving normal antenatal care only and (ii) participants receiving the programme of self-help booklets in addition to normal antenatal care. 112 participating midwives will be randomly allocated to the two groups: during the period of the trial, each of the midwives will deliver care according to their respective allocation to experimental group to all their patients satisfying the inclusion criteria.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Primary end point: smoking cessation rate (validated by urinary cotinine assay) at end of second trimester of pregnancy (27 weeks).

Secondary outcome measures

Secondary end points: birth weight and gestation at delivery. The acceptability of the intervention to participants and midwives, aspects of programme content and delivery and programme costs will also be assessed

Overall trial start date

01/02/1998

Overall trial end date

28/02/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Aged 16 years or above at their first appointment with one of 40 participating midwives. Participants will be those who are less than 16 weeks pregnant at that time and who were smokers immediately prior to pregnancy.